NCT05802914

Soft Active Back Exosuit to Reduce Workplace Back Pain

Efficacy of Soft Active Back Exosuit to Reduce the Risk of Occupational Low Back Pain and Injuries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Wyss Institute at Harvard University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine if a wearable back exosuit can make it safer and easier for workers who bend, lift, and lower objects in an industrial setting. Many studies have shown that wearable back exoskeletons or exosuits can provide helpful forces making a person's back muscles work less. It is believed that exosuits can lower a person's level of workplace effort and fatigue, making it less likely for them to have back pain at work. Back exosuits could be a solution to make a job easier, but how well they work in the real-world over a long period of time is unclear. The investigators want to know if workers who wear a back exosuit during the workday will have lower rates of lower back pain or injury than those who are not wearing a back exosuit. The investigators also want to know how well exosuit technology integrates into the workplace (for example, how this technology improves or hinders job performance). Participants will be randomized into an exosuit group or control group. Participants in the exosuit group will be given a back exosuit that they can use as much as they want at work. All participants will complete surveys monthly. Researchers will compare the exosuit group to the control group to see if using a back exosuit in a workplace can reduce a person's risk and impact of low back injury or pain. The investigators also want to see if a back exosuit impacts job productivity and if participants find the exosuit becomes useful or bothersome over time.

Conditions

• Low Back Pain
• Musculoskeletal Pain
• Low Back Injury

Interventions

Type	Name	Description
DEVICE	Back Exosuit	The back exosuit is a soft wearable robotic suit designed to improve a wearer physiology, kinetics, kinematics to reduce the possibility of injury. The back exosuit is primarily composed of textiles that wrap around an individual's shoulder (backpack) and thighs (thigh wrap) to serve as anchor points. An actuating element attaches to those anchor elements to provide assistive forces while the user performs a physical activity. The soft wearable robot integrates sensing components to be able to detect user biomechanics and device function and actuating elements via algorithms that command the actuation based on users' intent. To encourage usability, the device is easy to don and intuitive to use. This back exosuit has demonstrated significant reductions in back (18%), hip (11%) and knee (22%) extensor muscle activity during a 1-hour workplace simulation task when compared to lifting without a suit.

Timeline

• Start date: 2023-02-08
• Primary completion: 2025-04-26
• Completion: 2025-04-26
• First posted: 2023-04-07
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study